Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Cryoballoon Pulmonary Vein Isolation - PVI

• Registration Number: NCT03786822
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial fibrillation.

One group of subjects will have the procedure performed with intracardiac echo maneuvers to assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of subjects who will receive the standard medical treatment with fluoroscopy and angiography.

Detailed Description

Surgical and catheter based technologies target triggers that initiate atrial fibrillation located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency energy or freezing is used to destroy the atrial tissue which propagate electrical impulses into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and efficacious under fluoroscopic guidance with contrast angiography. The objective of this study is to identify methods to reduce radiation dose and radio opaque contrast use while maintaining PVI efficacy and safety.

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2016-12-20
• Study Completion: 2016-12-20
• Study First Submitted: 2018-11-29
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-20
• Last Update Submitted: 2018-12-20
• Study First Posted: 2018-12-26
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Paroxysmal atrial fibrillation refractory to treatment with anti-arrhythmic drugs
• Must be able to undergo pre-operative cardiac CT angiogram or cardiac MRI to define pulmonary vein anatomy.

Exclusion criteria:

• Planned use of radiofrequency cardiac ablation
• Presence of a cardiac implantable electronic device
• Conditions where manipulation of the catheter would be unsafe such as intracardiac thrombus
• Patients with active systemic infections
• Patients with cryoglobulinemia
• Pregnant and/or breast-feeding females are excluded from this study.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoroscopic Cryoballoon PVI	Cryoballoon Pulmonary Vein Isolation - PVI	Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography
Non-fluoroscopic Cryoballoon PVI	Cryoballoon Pulmonary Vein Isolation - PVI	1. Observation of pressure waveform change at the tip of the cryoballoon catheter from left atrial pressure to pulmonary vein pressure waveform. 2. Intracardiac echocardiography (ICE) imaging with no Doppler color evidence of peri-balloon high velocity leaks. 3. Intracardiac echo imaging showing no evidence of leak during agitated saline contrast injection into cryoballoon catheter positioned at pulmonary vein ostium.

Primary Outcome Measures

Name	Time	Method
Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.	one year	change in the composite endpoint of total fluoroscopy time (min)
Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.	one year	change in the composite endpoint of contrast (cc)

Secondary Outcome Measures

Name	Time	Method
Time to Cryoballoon Pulmonary Vein Isolation	one year	•cryoballoon procedure time (min)
Recurrence of atrial fibrillation	one year	•recurrence of atrial fibrillation after 1 month blanking period measured by ECG event monitoring at 6 and 12 month follow up (time to first recurrence in months, total number of episodes, and total duration in hours)

Trial Locations

Locations (1)

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States